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Aplicando el estado del arte y

libertad para operar en la


investigación y desarrollo

Cecilia Chi-
Chi-Ham
Directora Ciencia y Tecnología
clchiham@ucdavis.edu
PIPRA, UC Davis

PROGRAMA FIA - PIPRA


LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓN
AGROALIMENTARIA
www.iphandbook.com

En las áreas agrícola, es cada día mas


importante entender el rol de los patentes y
la propiedad intelectual en investigación,
desarrollo, y comercialización.
Patent Databases
 Free
– USPTO (Free and $ portals)
• Patent Application Information Retrieval (PAIR): http://portal.uspto.gov/external/portal/pair
• Patents/applications http://www.uspto.gov/patft/index.html
• Patent assignment http://assignments.uspto.gov/assignments/?db=pat
– European Patent Office esp@cenet.com
– Google Patent http://www.google.com/ptshp?tab=wt
– PIPRA Ag-IP www.search.pipra.org
– CAMBIA Patent Lens http://www.patentlens.net/daisy/patentlens/patentlens.html
– NCBI:PubMed www.pubmed.gov

 Subscription/fee based
– GenomeQuest www.genomequest.com
– Delphion www.delphion.com
– Others: Westlaw, Lexis, STN, etc.

Explore other Databases and Resources


www.PIPRA.org
www.search.pipra.org
PATENTES INIA LA CRUZ, Robison Vargas, Director
Asociad Vinculación empresa
Nombre Solicitud o
Matriz para la atracción y consumo de avispas En proceso de licenciamiento con
Vespula sp. Que comprende un alimento a empresa nacional y conversaciones con
base de carne animal; cebo que comprende la empresas extranjeras
matriz antes mencionada. 03208-2007
Uso de extractos Etanólicos de Cuesco de
Palta Persea americana Mill, variedad Hass, Formación de Consorcio empresarial,
como Acaricidas e Insecticidas 03612-2007 PUCV entre empresarios e INIA
Uso de compuestos químicos orgánicos En proceso de licenciamiento con
individuales del tipo alcoholes, aldehidos y empresa nacional y conversaciones con
cetonas, como atrayentes de la avispa V. empresas extranjeras
germanica 03850-2007
En proceso de licenciamiento con
empresa nacional y conversaciones con
empresas extranjeras
Estación Cebo para avispas chaqueta amarilla 0226-2008
Equipo y método de limpieza de productos
agrícolas y de huevos de gallina mediante
aspersión con agua a presión 3272-2008
Estado de Arte para Implementación de Proyectos

PIPRA provee análisis de estado del arte de patentes


para apoyar desarrollo y adopción de proyectos y
productos. Red PIPRA:
Estudios y Servicios Legales (alugnos, pro bono)

Identifica elementos de PI que pueden afectar I&D.


Townsend and Towsend and Crew
DLA Piper Rudnick Gray Cary
Panorama del momento
MorrisondelandEstado
Foersterdel Arte de pantes
Harness, Dickey and Pierce
en un área de tecnología.
Foley Hoag
Edwards & Angell
Baker & McKenzie
Public Interest IP Attorneys (PIIPA)
Fulbright & Jaworski
Pierce Law, Franklin Pierce Law Center
Freedom to Operate FTO
Libertad para Operar
…is an ongoing legal assessment of the
intellectual property rights covering a
particular technology space.

…performed to ensure that a new


innovation does not infringe other’s
intellectual property.
Estrategias de Manejo de PI en
base a Análisis de Estado de Arte

 Abandon or modify business/research goals (field of use,


geographies)
 Assume current path despite FTO risk evaluation (can
one tolerate risk of infringement litigation?)
 Replace with substitute technologies with greater FTO
 Purchase the Patent(s) or In-License rights
 Cross-License
 Invent around the blocking patent
 Develop a patent pool or a clearinghouse
Proceso de Análisis Estado de Arte
I. Define Subject Matter
II. Formulate Team
III. Define Questions and IP Search
Strategy
IV. Investigation
V. Product of the Search
I. Definir Tecnología para Estado de Arte
 Define subject mater
– Describe technology
– Anticipated field of use

 Dissect the technology


– Identify technologies used to make the product including:
• Trait genes, germplasm, selectable markers, transformation technologies,
methodologies, etc.
• Material transfer agreements and property trail
– Distinguish ‘core’ and ‘substitutable’ technologies

 Geographies
– Countries in which the product will be developed, manufactured,
approved by regulatory agencies, and marketed/sold

 Time-frames
– Awareness of 18 month period of periods of silence of US patent
applications
– Patent Maintenance or Life-time (US 17 or 20 years)
– ONGOING analysis to be performed as early in the development phase as
possible.
II. Formular Equipo
Stanton Gelvin, Purdue University
Kan Wang, Iowa State University
SCIENTISTS Pal Maliga, Rutgers University
David Ow, USDA-ARS, UC Berkeley
Brian Miki, Agriculture and Agri-Food Canada
Vibha Srivastava, University of Arkansas
Chris Taylor, Donald Danforth Plant Science Center

David Tricoli, University of California Davis


Francois Torney, Iowa State University
Robert Houtz, University of Kentucky

Michael Lang, Harness, Dickey & Pierce, P.L.C.


Michael Ward, Morrison & Foerster LLP
Attorneys Clinton Neagley, University of California, Davis
Charles McManis, Washington University Law School
James Surber, Patent Attorney, Bryan Cave Chuck LLP
Chuck McManis, Washington University School of Law

Ag-
Ag-Biotech Companies Robert Horsch, Monsanto
Qi Wang, Monsanto
Keith Redenbaugh, Seminis Vegetable Seeds
Regulatory Experts
Kathy Swords, Biotech Business Development, J.R. Simplot Company

Alan Bennett, PIPRA, University of California Davis


Karel Schubert, Donald Danforth Plant Science Center
PIPRA Sara Boettiger, PIPRA, University of California Berkeley
Cecilia Chi-Ham, PIPRA, University of California Davis
III. Define Questions
 Interview and laboratory history

– Interview scientific, technical, and technology transfer/IP


staff
– Technical description of the technology
Review published literature, presentations, research proposals, etc.
– Deconstruction of the technology components, methods,
protocols, germplasm etc.
– Acquisition trail: MTA—who got what from whom?
– Source of research funds, confidentiality agreements,
employment agreements
IP restrictions imposed by funding sources, collaborators, universities, etc.

 Meticulously develop series of questions congruent


with the projects immediate and future goals.
IV. Nivel I Estado de Arte/Libertad para Operar

Are there blocking patents that could preclude pursuing a new goal?
Based on Public information

 Review Patent Search Results


 Identify Patents (present risks)
 Identify Patent Applications (potential future risks)
 Determine IP Ownership and Status
 Maintenance Status-- anticipated expiration date, abandoned, etc.
 Check Assignment Records
 Availability/Licensing information
o Usually not public information (PIPRA-Network)
Nivel II Estado de Arte/Libertad para Operar
Patent Landscape | Based on Public information

 Construct IP Priority Timeline and “Landscape”


– Group Patent Risks by Subject Matter
– Determine relative Patent Dominance
• priority date
• broader vs. narrower patents-- Broader patents may have leverage to seek
higher fees/control entry into the market
– Timeline of public information ‘prior art’ with patent history
– Construct Vertical / International Families
– Claim analysis by legal counsel
– Obtain & Evaluate Patent File Histories
 Check Patent Litigation Records
– Held Invalid? Unenforceable?
– Interferences?
cont… Nivel II.

 Check Business and News Records


 Patentee’s Website / Annual Report
 SEC Filings by Patentee – “Risks”
 Press Releases by Patentee
 Industry-Specific and General News Reports
 Is the Patentee likely to Enforce IP rights?
Nivel III. Estado de Arte/FTO
Patent Landscape | Requires Confidential Information and
Cooperation from Patentee, Contracts and Grants and Tech
Transfer Offices

 Unpublished Patent Applications


– U.S. Provisional Applications
– U.S. Utility Applications < 18 months
– File Histories of Pending Applications
 Unpublished research data, manuscripts
 Business Goals / Project Status
 Threatened Litigation
cont… Nivel III

 Contracts affecting Ownership


– Assignments, Licenses
– Funding/research agreements
– Availability/Licensing information
• Usually not public information
• PIPRA’s ag-IP portfolio includes licensing information
V. Producto de Análisis de Estado de Arte
 Attorney-Client Privilege
– According to US law product of FTO search is considered attorney-
client privilege information
– Information remains confidential if the client chooses to do so
– Not all legal counsel are attorneys
…thus Degree of protection may vary
Such terms should be discussed in advance
 Oral Advice of Counsel
 Written Report
– Scope of Search, Search Strategies
– Listing of Identified Risks
– Analysis of Identified Risks
 Formal Written Opinion
– Noninfringement or Invalidity
 Patent Landscape Changes over Time
– FTO product is a “Living Document” and requires constant updates
Caso 1

VISTA PANORAMICA DEL


ESTADO DEL ARTE
Estado de arte de Biocombustibles

Clark, Jensen, et al. Estudio PIPRA

Research Sponsored by:


US Department of Energy,
Chevron, & BP
Mas de 1400 patentes y aplicaciones relacionadas
con producción de EtOH ligno-
ligno-cellulosico.
cellulosico.

No. patents and applications

Clark, Jensen, et al. Estudio PIPRA


Distribución de Patentes por Tecnología y Sector

C’ PROCESSES
PRETREATMENT SACCHARIF’N FERMENTATION
Chemical Physical CA/PH Enzymes Process Enzymes EEO Process

Genencor USA
Novozymes USA
Dupont USA

Novo Nordisk USA


Verenium
BASF
Andritz
USA
Germany
Austria
Private
DSM Netherlands
AB Enzymes Germany

Midwest Research Institute USA


University of Florida USA
Dartmouth USA

Lund University
Hebrew University of Jerusalem
Sweden
Israel
Public
Iogen Energy Corp Canada
Arkenol USA

Clark, Jensen, et al. Estudio PIPRA No. patents and applications

=0 1-5 6-10 11-20 21-40 >100


Caso 2

LIBERTAD DE OPERAR
SUBSITUYENDO TECNOLOGIAS
Technical audits of Expression Construct
for path to commercialization
DSF in Transgenic Grape Rootstocks LB
PIPRA Recombinase Gene-
Gene-Excision Vector
RRS

MAS Purdue Univ.


LB
Monsanto Company
Rockefeller University DEF2
Univ. Kentucky
35S MAS3’UTR
Monsanto
IP/34S Rockefeller Univ
nptII UCalifornia

Eili/Lilly Recomb
Novartis Hyg
USDA
nos3’UTR 35S 3’UTR
Monsanto
34S Univ. California

Cyt Deam
Monsanto Company
35S NOS 3’UTR
Rockefeller University
RRS
Univ. California
No IPRS identified rpfF of X. campesti 34S
No IPRS identified rfpF of X. fastidiosa
rpfF of X. campesti
No IPRS identified
Monsanto ???? rpfB of X. campestris
rfpF of X. fastidiosa
Nos 3’UTR No IPRS identified
rpfB of X. campestris
PVPs Monsanto ????
Nos 3’UTR
Agro-bacteria
Mediated RB
Transformation RB
Caso 3

CONSIDERANDO TECNOLOGIA
DOMINIO PUBLICO O PATENTADA
3/2009 Revista Science: RNAI Descubrimiento del Año
Fire and Mello 2006 Premio Nobel Fisiología y Medicina
RNAi tecnología para suprimir
la expresión de genes de una
forma directa y eficiente.

Potencial para:
Terapéutica humano
Biotecnología en Agricultural
Otras

http://nobelprize.org/nobel_prizes/medicine/l
aureates/2006/press.html
Gene Suppression in Genetically Improved
Specialty Crops

1982, Calgene
Commercialized first
transgenic crop

Calgene FLAVRSAVRTM
Polygalacturonase
antisense
Delayed fruit ripening
Unpublished Data, 2009 Chi-Ham, Clark, Bennett
Caso 4

ARMANDO PAQUETES
TECNOLOGICOS
PIPRA’s Plant Transformation
Marker Free Technology Platforms

3. Excision marker
Univ California
1. Selectable markers
MAS Promoter, BRCD/Purdue 4. Transposase
NPTII Univ California
2. Constitutive Promoters
Univ California,
Cornell Univ.,
AgriFood Canada,

•Comprised of multiple patented components (PIPRA Members)


•Incorporates technical, legal, and regulatory design features
•Compatible with:
– Agrobacteria and Non-Agrobacteria strains (Transbacter, Cambia)
– T-DNA transfer borders from Agrobacteria or Plant Derived
IP Strategy – pPIPRA Vector Licensing
Model

Plant Transformation
Technology Providers
Pre-negotiated licensing terms

humanitarian
use
PIPRA
Design, test, and disseminate plant research use
transformation vector Materials under
Research/Commercial
MTA/Licenses
commercial use

Royalty free
Fee
based
Revenue flow
Colaboraciones publico-privado para
desarrollar tecnologías.

Arroz con uso Eficiente de Nitrógeno y


Tolerancia a Suelos Salinos para pequeños
agricultores en África.
 Arcadia Biosciences, provides trait technologies
 PIPRA, transformation technologies under
humanitarian, royalty-free terms
 AATF (African Agricultural Technology
Foundation), facilitates collaboration
 USAID-Funding
Aplicando el estado del arte de la
información en la investigación

Cecilia Chi-
Chi-Ham
Directora Ciencia y Tecnología
clchiham@ucdavis.edu
PIPRA, UC Davis
PROGRAMA FIA - PIPRA
LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓN
AGROALIMENTARIA
II. Formular Equipo
 Develop a team capable of analyzing all
aspects of the product development

 Build multidisciplinary team

– Technical: scientific, biotech, pharma

– IP/technology transfer, patent agents, internal or


external legal counsel
• Legal counsel/ patent attorneys may be sought only if the warranted (later
stages, significant legal questions)
• Consider pro-bono legal counsel (i.e. Public Interest Intellectual Property
Advisors); IP service groups (MIHR, PIPRA, university)

– Regulatory & business development experts